AccessGUDID - DEVICE: Q-Sense CPM Thermal Sensory Analazer (07290103039257)

GUDID

Device Identifier (DI) Information

Brand Name: Q-Sense CPM Thermal Sensory Analazer
Version or Model: Q-Sense CPM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MO 00013-CPM
Company Name: MEDOC LTD.

Primary DI Number: 07290103039257
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600469191 *Terms of Use

Device Description: The Q-Sense CPM Thermal Sensory Analyzer is a QST (Quantitative Sensory Testing) device including advanced software package designed for clinical use and advance research in the field of Pain Management. The CPM Model offers additional capabilities to the Q-Sense device including: Simultaneous operation of two Thermodes, Ramp & Hold method, Computerized Visual Analog Scale (CoVAS). The Device includes: main unit, two thermodes and accessories.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37350	Thermotester, diagnostic	A mains electricity (AC-powered) device designed to provide quantitative diagnostic evaluation of a patient's reaction to thermal stimuli, typically on the skin surface, by providing information on threshold to heat or cold perception. The device typically operates by gradually increasing the temperature to 42 - 50? Celsius. It is typically used to diagnose early diabetes mellitus, for phantom pain detection, neurological studies of thin fibre nerve systems, and also for pain threshold investigations.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LQW	Test, Temperature Discrimination

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K922052	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 259ff125-a5ba-4143-b16c-5cb338db11c3
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 24, 2016